Conscious Sedation vs General Anesthesia in TAVR Patients

Montefiore Medicine Academic Health System

Status: Withdrawn

Conditions: Aortic Stenosis

Treatments: Procedure: General Anesthesia; Procedure: Conscious Sedation

Study type: Interventional

Funder types: Other

Identifiers

NCT03084978

2016-7021

Details and patient eligibility

About

This is a randomized controlled trial investigating the effect of general anesthesia versus conscious sedation on operative times in patients undergoing transcatheter aortic valve replacement.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Signed informed consent, signed Health Insurance Portability and Accountability Act (HIPAA) documentation)
2. Age over 18 years of age.
3. Women of child bearing age must have a negative urine or serum pregnancy test.
4. Clinical indication for a transfemoral aortic valve replacement.
5. English or Spanish speaking
6. No evidence of neurological impairment as defined by a NIHSS ≤ 1 and modified Rankin scale (mRS) ≤ 2 within 7 days prior to randomization.

Exclusion criteria

1. BMI > 40
2. Diagnosis of severe obstructive sleep apnea based on previous polysomnography, with severe defined as an apnea-hypopnea index (AHI) >30 episodes/hr.
3. High risk for aspiration such as severe esophageal disease (e.g. achalasia, gastroparesis, etc).
4. Inability to lie supine for more than 30 minutes.
5. Marginal femoral vessels with concern for possible conversion to transapical or transaortic access.
6. Patient refusal
7. Patient involved in another research study
8. Psychiatric condition precluding ability to provide informed consent
9. History of clinical stroke within 3 months prior to randomization

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

General Anesthesia

Active Comparator group

Description:

Subjects will undergo general anesthesia with endotracheal intubation.

Treatment:

Procedure: General Anesthesia

Conscious Sedation

Experimental group

Description:

Subjects will undergo conscious sedation anesthesia.

Treatment:

Procedure: Conscious Sedation